Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy

Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Single-center, Prospective, Open-label, Randomized, Controlled Trial

This single-center, prospective, open-label, randomized, controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy. The primary objectives include investigating:

Question 1: The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy.

Question 2: The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction, mid-left ventricular obstruction, and in individuals with or without organic valvular lesions.

Question 3: The effects of the two surgical procedures on exercise capacity, quality of life, and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction, both with and without valvular lesions.

Participants will be stratified into two groups. The experimental group will undergo thoracoscopic Morrow surgery, while the control group will undergo median open modified enlarged Morrow surgery.

Study Overview

• Status: Recruiting
• Conditions: Minimally Invasive Surgery; Cardiomyopathy, Hypertrophic Obstructive
• Intervention / Treatment: Procedure: thoracoscopic Morrow surgery; Procedure: modified Morrow surgery

Detailed Description

This study is a single-center, prospective, open-label, randomized, controlled trial designed to investigate the therapeutic value of thoracoscopic Morrow procedure in patients with hypertrophic obstructive cardiomyopathy (HOCM). The study focuses on HOCM patients, with the modified extended Morrow procedure via median sternotomy considered as the 'gold standard treatment' in the control group. The objective is to explore the efficacy of the thoracoscopic Morrow procedure in improving exercise tolerance in HOCM patients, assess the short-term and long-term effectiveness, safety, as well as changes in cardiac function, cardiac structure, and myocardial fibrosis levels associated with thoracoscopic Morrow procedure in treating obstructive HOCM.

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Wang; Phone Number: 13901036490; Email: fuwaiwangxin@188.com
• Study Contact Backup: Name: Lei Song; Phone Number: 13810532620; Email: songlqd@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Xin Wang; Phone Number: 13901036490; Email: fuwaiwangxin@188.com
    • Contact: Lei Song; Phone Number: 13810532620; Email: songlqd@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosed with hypertrophic cardiomyopathy (HCM);
• age ≥18 years old;
• presence of left ventricular outflow tract/mid-ventricular obstruction, with a resting left ventricular outflow tract pressure gradient/left ventricular cavity pressure gradient ≥50 mmHg; significant symptoms persist despite optimal medical therapy, and surgical evaluation indicates the need for intervention;
• left ventricular ejection fraction (LVEF) ≥55%;
• signed informed consent, willing and able to return to the hospital for follow-up.

Exclusion Criteria:

• previously underwent septal reduction therapy (including surgical or interventional procedures);
• received or planning to receive an implantable cardioverter-defibrillator (ICD) in the past 3 months;
• individuals with concomitant conditions requiring simultaneous surgical intervention;
• New York Heart Association (NYHA) functional class IV;
• unwilling to undergo surgical treatment;
• pregnant or lactating or planning pregnancy;
• previously participated in other clinical trials before enrollment;
• individuals with concurrent diseases with an expected lifespan of less than 1 year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracoscopic trans-mitral myectomy; patients who undergo thoracoscopic Morrow procedure	Procedure: thoracoscopic Morrow surgery; minimally invasive trans-mitral Morrow septal myectomy
Active Comparator: Modified extended Morrow myectomy; patients who undergo modified extended Morrow myectomy	Procedure: modified Morrow surgery; median open modified enlarged Morrow septal myectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular outflow tract gradient variability	Change in Left ventricular outflow tract gradient pre- and post- intervention	6 months,9 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk distance	A measure used to assess the functional exercise capacity of individuals. It is determined by the distance a person can walk in 6 minutes on a flat, hard surface.	6 months,9 months and 12 months
New York Heart Association Functional Classification of Heart Failure	A system used to categorize the severity of heart failure based on the functional limitations of individuals.	6 months,9 months and 12 months
Marker of myocardial injury	To assay the concentration of proteins(cardiac troponin T, cardiac troponin I)associated with myocardial injury.	6 months,9 months and 12 months
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score	A disease-specific health status measure designed to assess the impact of heart failure on patients' quality of life.	6 months,9 months and 12 months
Echocardiographic indicator	Left ventricular ejection fraction assessed by echocardiography.	6 months,9 months and 12 months
Cardiac magnetic resonance indicator	The left ventricular mass index was assessed using cardiac magnetic resonance imaging.	6 months,9 months and 12 months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xin Wang, Fuwai Hospital, National Centre for Cardiovascular Disease; Principal Investigator: Lei Song, Fuwai Hospital, National Centre for Cardiovascular Disease

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 2023-ZX013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No